Home About us Contact
|
Home About us Contact | ||
|
|
||
Randomised Controlled Trials (randomised + controlled_trials)
Selected AbstractsManaging childhood obesity: when lifestyle change is not enoughDIABETES OBESITY & METABOLISM, Issue 11 2010C. Hearnshaw The management of childhood obesity is a clinical dilemma. Paediatricians will see those children whose weight is at the severe end of the spectrum with obesity-related co-morbidities and for whom more intensive weight loss therapies may be appropriate. A literature review was performed (January 1995,January 2010) of the roles of pharmacotherapy or bariatric surgery in the management of childhood obesity. Three hundred and eighty-three abstracts were reviewed and 76 full-text articles were requested. Of these, 34 were excluded and a total of 21 pharmacotherapy papers and 22 papers on surgery were reviewed in detail. All studies involved adolescents. Pharmacotherapy: Most studies were small and of short duration, the notable exceptions being two large RCTs of sibutramine and orlistat. Sibutramine led to a mean estimated change in BMI from baseline of ,3.1 kg/m2 vs. ,0.3 kg/m2 for placebo over 12 months. Orlistat was also beneficial with a mean reduction in BMI of 0.55 vs. an increase of 0.31 kg/m2 in the placebo group at 12 months. Bariatric surgery: Most papers presented clinical observations and there were no randomised controlled trials (RCTs). Robust selection criteria were not used and ideal candidate selection remains unclear. Most papers showed a significant benefit of surgery in severely obese adolescents in the short term but long-term data were sparse. There were a surprisingly large number of papers examining the benefits of intensive weight management in obese adolescents. The study design of many was inadequate and the role of pharmacotherapy or surgery in childhood obesity remains unclear. [source] A cost-effectiveness analysis of modafinil therapy for psychostimulant dependenceDRUG AND ALCOHOL REVIEW, Issue 3 2010JAMES SHEARER Abstract Introduction and Aims. To examine the cost-effectiveness of modafinil (200 mg daily) plus counselling compared with placebo for the treatment of psychostimulant dependence. Design and Methods. Cost and outcome data were collected alongside two randomised controlled trials of modafinil 200 mg daily over 10 weeks for methamphetamine (n = 74) and cocaine dependence (n = 8), respectively. Incremental cost-effectiveness ratios representing the additional costs to achieve a given outcome were calculated for both the change in the number of stimulant-free days and quality-adjusted life years 12 weeks post-treatment. Results. The incremental cost-effectiveness ratio indicated that it would cost an additional $AUD79 to achieve an extra stimulant-free day with modafinil compared with placebo. This result was not statistically significant, but appeared to be a robust estimate after sensitivity analysis. Counselling, whether received within program or from other services, improved the cost-effectiveness of modafinil relative to placebo. Discussion and Conclusions. Strategies to improve the uptake of counselling are recommended as cost-effective.[Shearer J, Shanahan M, Darke S, Rodgers C, van Beek I, McKetin R, Mattick RP. A cost-effectiveness analysis of modafinil therapy for psychostimulant dependence. Drug Alcohol Rev 2010] [source] Botulinum toxin injection therapy in the management of lower urinary tract dysfunctionINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2006A. K. PATEL Summary We have great pleasure in introducing this supplement containing a collection of articles reviewing the contemporary clinical management of functional disorders of the lower urinary tract (LUT) with particular emphasis on the potential role of botulinum toxin injection therapy. Detrusor sphincter dyssynergia (DSD), detrusor overactivity (DO), painful bladder syndrome (PBS) and LUT symptoms consequent on bladder outflow obstruction (LUTS/BPH) have all been treated by the injection of botulinum toxin. This treatment can be administered as a minimally invasive, outpatient procedure which on the initial trials for DO (particularly of neurogenic aetiology) shows a remarkable efficacy with effects lasting up to a year after a single treatment with few significant side effects. Success has been reported with the management of detrusor sphincter dyssynergia and preliminary series report positive outcomes in the management of PBS and LUTS/BPH. However, most of the studies to date include small numbers and have a recruitment bias with few randomised controlled trials having been reported. The answers to some of the key questions are addressed with reference to our contemporary knowledge. It is clear that considerable work both clinical and basic science still needs to be performed to answer the many remaining questions with regard to this treatment modality but undoubtedly it will be a major future treatment option in those with intractable symptoms or those unable to tolerate medications. Currently, all botulinum toxin use for urological conditions is off-label and unlicensed, therefore caution should be exercised until future large randomised studies are reported. [source] Cognitive leisure activities and their role in preventing dementia: a systematic reviewINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 1 2010Cindy Stern BHSc(Hons) Abstract Background, Dementia inflicts a tremendous burden on the healthcare system. Identifying protective factors or effective prevention strategies may lead to considerable benefits. One possible strategy mentioned in the literature relates to participation in cognitive leisure activities. Aim, To determine the effectiveness of cognitive leisure activities in preventing Alzheimer's and other dementias among older adults. Inclusion criteria Types of participants.,Adults aged at least 60 years of age with or without a clinical diagnosis of dementia that resided in the community or care setting. Types of interventions.,Cognitive leisure activities, defined as activities that required a mental response from the individual taking part in the activity (e.g. reading). Types of outcomes.,The presence or absence of dementia was the outcome of interest. Types of studies.,Any randomised controlled trials, other experimental studies, as well as cohort, case,control and cross-sectional studies were considered for inclusion. Search strategy.,A search for published and unpublished studies in the English language was undertaken with no publication date restriction. Methodological quality, Each study was appraised independently by two reviewers using the standard Joanna Briggs Institute instruments. Data collection and analysis, Information was extracted from studies meeting quality criteria using the standard Joanna Briggs Institute tools. Because of the heterogeneity of populations and interventions, meta-analyses were not possible and results are presented in narrative form. Results, There were no randomised controlled trials located that met inclusion criteria. Thirteen observational studies were included in the review; the majority were cohort design. Because of the heterogeneity of interventions, the study design, the way in which they were grouped and the different stages of life they were measured at, statistical pooling was not appropriate. Studies were grouped by stage of adult life participation when interventions were undertaken, that is, early adulthood, middle adulthood and late life. Five out of six studies showed a positive association between participating in activities and a reduced risk of developing Alzheimer's disease and other dementias when interventions were undertaken in middle adulthood and six out of seven studies produced a positive association for late life participation. Results indicated that some activities might be more beneficial than others; however, results should be interpreted with caution because of the subjective nature of activity inclusion. Conclusion ,,Actively participating in cognitive leisure activities during mid- or late life may be beneficial in preventing the risk of Alzheimer's disease and other dementias in the elderly; however, the evidence is currently not strong enough to infer a direct causal relationship. ,,Participating in selected cognitive leisure activities may be more favourable than others but currently there is no strong evidence to recommend one over the other. [source] Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic reviewINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 2 2008Deborah Parker BA, MSocSci Executive summary Objectives, The objective of this review was to assess the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community. Inclusion criteria, Types of participants, Adult caregivers who provide support for people with dementia living in the community (non-institutional care). Types of interventions, Interventions designed to support caregivers in their role such as skills training, education to assist in caring for a person living with dementia and support groups/programs. Interventions of formal approaches to care designed to support caregivers in their role, care planning, case management and specially designated members of the healthcare team , for example dementia nurse specialist or volunteers trained in caring for someone with dementia. Types of studies, This review considered any meta-analyses, systematic reviews, randomised control trials, quasi-experimental studies, cohort studies, case control studies and observational studies without control groups that addressed the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community. Search strategy, The search sought to identify published studies from 2000 to 2005 through the use of electronic databases. Only studies in English were considered for inclusion. The initial search was conducted of the databases, CINAHL, MEDLINE and PsychINFO using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group. A second more extensive search was then conducted using the appropriate Medical Subject Headings (MeSH) and keywords for other available databases. Finally, hand searching of reference lists of articles retrieved and of core dementia, geriatric and psycho geriatric journals was undertaken. Assessment of quality, Methodological quality of each of the articles was assessed by two independent reviewers using appraisal checklist developed by the Joanna Briggs Institute and based on the work of the Cochrane Collaboration and Centre for Reviews and Dissemination. Data collection and analysis, Standardised mean differences or weighted mean differences and their 95% confidence intervals were calculated for each included study reported in the meta-analysis. Results from comparable groups of studies were pooled in statistical meta-analysis using Review Manager Software from the Cochrane Collaboration. Heterogeneity between combined studies was tested using standard chi-square test. Where statistical pooling was not appropriate or possible, the findings are summarised in narrative form. Results, A comprehensive search of relevant databases, hand searching and cross referencing found 685 articles that were assessed for relevance to the review. Eighty-five papers appeared to meet the inclusion criteria based on title and abstract, and the full paper was retrieved. Of the 85 full papers reviewed, 40 were accepted for inclusion, three were systematic reviews, three were meta-analysis, and the remaining 34 were randomised controlled trials. For the randomised controlled trials that were able to be included in a meta-analysis, standardised mean differences or weighted mean differences and their 95% confidence intervals were calculated for each. Results from comparable groups of studies were pooled in statistical meta-analysis using Review Manager Software and heterogeneity between combined studies was assessed by using the chi-square test. Where statistical pooling was not appropriate or possible, the findings are summarised in narrative form. The results are discussed in two main sections. Firstly it was possible to assess the effectiveness of different types of caregiver interventions on the outcome categories of depression, health, subjective well-being, self-efficacy and burden. Secondly, results are reported by main outcome category. For each of these sections, meta-analysis was conducted where it was possible; otherwise, a narrative summary describes the findings. Effectiveness of intervention type, Four categories of intervention were included in the review , psycho-educational, support, multi-component and other. Psycho-educational Thirteen studies used psycho-educational interventions, and all but one showed positive results across a range of outcomes. Eight studies were entered in a meta-analysis. No significant impact of psycho-educational interventions was found for the outcome categories of subjective well-being, self-efficacy or health. However, small but significant results were found for the categories of depression and burden. Support Seven studies discussed support only interventions and two of these showed significant results. These two studies were suitable for meta-analysis and demonstrated a small but significant improvement on caregiver burden. Multi-component Twelve of the studies report multi-component interventions and 10 of these report significant outcomes across a broad range of outcome measures including self-efficacy, depression, subjective well-being and burden. Unfortunately because of the heterogeneity of study designs and outcome measures, no meta-analysis was possible. Other interventions Other interventions included the use of exercise or nutrition which resulted in improvements in psychological distress and health benefits. Case management and a computer aided support intervention provided mixed results. One cognitive behavioural therapy study reported a reduction in anxiety and positive impacts on patient behaviour. Effectiveness of interventions using specific outcome categories, In addition to analysis by type of intervention it was possible to analyse results based on some outcome categories that were used across the studies. In particular the impact of interventions on caregiver depression was available for meta-analysis from eight studies. This indicated that multi-component and psycho-educational interventions showed a small but significant positive effect on caregiver depression. Five studies using the outcome category of caregiver burden were entered into a meta-analysis and findings indicated that there were no significant effects of any of interventions. No meta-analysis was possible for the outcome categories of health, self-efficacy or subjective well-being. Implications for practice, From this review there is evidence to support the use of well-designed psycho-educational or multi-component interventions for caregivers of people with dementia who live in the community. Factors that appear to positively contribute to effective interventions are those which: ,,Provide opportunities within the intervention for the person with dementia as well as the caregiver to be involved ,,Encourage active participation in educational interventions for caregivers ,,Offer individualised programs rather than group sessions ,,Provide information on an ongoing basis, with specific information about services and coaching regarding their new role ,,Target the care recipient particularly by reduction in behaviours Factors which do not appear to have benefit in interventions are those which: ,,Simply refer caregivers to support groups ,,Only provide self help materials ,,Only offer peer support [source] Meta-analysis comparing clinical effectiveness of drug-eluting stents, bare metal stents and coronary artery bypass surgeryINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 3 2007Eun-Hwan Oh PhD MPH MHA BA Abstract Objective, To compare clinical outcomes among patients receiving drug-eluting stents, bare metal stents, or coronary artery bypass grafting surgery (CABG) to treat coronary artery disease. Data sources, Randomised controlled trials were systematically selected from electronic database for head-to-head comparisons. The results from these head-to-head comparisons were used for an adjusted indirect comparison. Methods, Published randomised controlled trials were reviewed for outcome data in patients treated for coronary artery disease with drug-eluting stents, bare metal stents, or CABG. Head-to-head comparisons were conducted for drug-eluting stents versus bare metal stents and for CABG versus bare metal stents. Adjusted indirect comparison was used to compare drug-eluting stents and CABG. Mid-term clinical outcomes (range: 6,12 months) were investigated and included rates of mortality, myocardial infarction, thrombosis, target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Results, Systematic literature search identified 23 randomised controlled trials (15 for drug-eluting stents vs. bare metal stents, 8 for CABG vs. bare metal stents). Head-to-head comparisons for both single and multiple vessel disease demonstrated that compared with bare metal stents, drug-eluting stents had better outcomes for target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Except target lesion revascularisation, data were similarly favourable for CABG when compared with bare metal stents. Adjusted indirect comparison between drug-eluting stents and CABG in single vessel disease failed to detect significant differences in any of the measured outcomes. Multiple vessel disease data analysis demonstrated that target vessel revascularisation (odds ratio 3.41 [95% CI 2.29,5.08]) and major adverse cardiac events (1.89 [1.28,2.79]) were superior to drug-eluting stents in patients undergoing CABG. Conclusions, Drug-eluting stents and CABG were superior to bare metal stents in terms of target lesion revascularisation (drug-eluting stents only), target vessel revascularisation, restenosis and major adverse cardiac events. There was no difference in clinical outcomes when comparing CABG and drug-eluting stents in patients with single vessel disease, and CABG may be superior to drug-eluting stents for target vessel revascularisation and major adverse cardiac events in patients with multiple vessel disease. However, results may vary between subpopulations with different clinical or socioeconomic differences. [source] Lack of evidence of the effectiveness of primary brachial plexus surgery for infants (under the age of two years) diagnosed with obstetric brachial plexus palsyINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 4 2006Andrea Bialocerkowski PhD M App Sc (Physio) M App Sc (Physio) Grad Dip Public Health Abstract Background, Obstetric brachial plexus palsy, which occurs in 1,3 per 1000 live births, results from traction and/or compression of the brachial plexus in utero, during descent through the birth canal or during delivery. This results in a spectrum of injuries that range in extent of damage and severity and can lead to a lifelong impairment and functional difficulties associated with the use of the affected upper limb. Most infants diagnosed with obstetric brachial plexus palsy receive treatment, such as surgery to the brachial plexus, physiotherapy or occupational therapy, within the first months of life. However, there is controversy regarding the most effective form of management. This review follows on from our previous systematic review which investigated the effectiveness of primary conservative management in infants with obstetric brachial plexus palsy. This systematic review focuses on the effects of primary surgery. Objectives, The objective of this review was to systematically assess and collate all available evidence on effectiveness of primary brachial plexus surgery for infants with obstetric brachial plexus palsy. Search strategy, A systematic literature search was performed using 13 databases: TRIP, MEDLINE, CINAHL, Web of Science, Proquest 5000, Evidence Based Medicine Reviews, Expanded Academic ASAP, Meditext, Science Direct, the Physiotherapy Evidence Database, Proquest Digital Dissertations, Open Archives Initiative Search Engine, the Australian Digital Thesis program. Those studies that were reported in English and published between July 1992 to June 2004 were included in this review. Selection criteria, Quantitative studies that investigated the effectiveness of primary brachial plexus surgery for infants with obstetric brachial plexus palsy were eligible for inclusion into this review. This excluded studies where infants were solely managed conservatively or with pharmacological agents, or underwent surgery for the management of secondary deformities. Data collection and analysis, Two independent reviewers assessed the eligibility of each study for inclusion into the review, the study design used and its methodological quality. Where any disagreement occurred, consensus was reached by discussion. Studies were also assessed for clinical homogeneity by considering populations, interventions and outcomes. Where heterogeneity was present, synthesis was undertaken in a narrative format. Results, Twenty-one studies were included in the review. Most were ranked low on the hierarchy of evidence (no randomised controlled trials were found), and most had only fair methodological quality. Surgical intervention was variable, as were the eligibility criteria for surgery, the timing of surgery and the outcome instruments used to evaluate the effect of surgery. Therefore, it is difficult to draw conclusions regarding the effectiveness of primary brachial plexus surgery for infants with obstetric brachial plexus palsy. Conclusions, Although there is a wealth of information regarding the outcome following primary brachial plexus surgery it was not possible to determine whether this treatment is effective in increasing functional recovery in infants with obstetric brachial plexus palsy. Further research is required to develop standardised surgical criteria, and standardised outcome measures should be used at specific points in time during the recovery process to facilitate comparison between studies. Moreover, comparison groups are required to determine the relative effectiveness of surgery compared with other forms of management. [source] Association between pacifier use and breast-feeding, sudden infant death syndrome, infection and dental malocclusionINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 6 2005Ann Callaghan RN RM BNurs(Hons) Executive summary Objective, To critically review all literature related to pacifier use for full-term healthy infants and young children. The specific review questions addressed are: What is the evidence of adverse and/or positive outcomes of pacifier use in infancy and childhood in relation to each of the following subtopics: ,breast-feeding; ,sudden infant death syndrome; ,infection; ,dental malocclusion. Inclusion criteria, Specific criteria were used to determine which studies would be included in the review: (i) the types of participants; (ii) the types of research design; and (iii) the types of outcome measures. To be included a study has to meet all criteria. Types of participants,The participants included in the review were healthy term infants and healthy children up to the age of 16 years. Studies that focused on preterm infants, and infants and young children with serious illness or congenital malformations were excluded. However, some total population studies did include these children. Types of research design, It became evident early in the review process that very few randomised controlled trials had been conducted. A decision was made to include observational epidemiological designs, specifically prospective cohort studies and, in the case of sudden infant death syndrome research, case,control studies. Purely descriptive and cross-sectional studies were excluded, as were qualitative studies and all other forms of evidence. A number of criteria have been proposed to establish causation in the scientific and medical literature. These key criteria were applied in the review process and are described as follows: (i) consistency and unbiasedness of findings; (ii) strength of association; (iii) temporal sequence; (iv) dose,response relationship; (v) specificity; (vi) coherence with biological background and previous knowledge; (vii) biological plausibility; and (viii) experimental evidence. Studies that did not meet the requirement of appropriate temporal sequencing of events and studies that did not present an estimate of the strength of association were not included in the final review. Types of outcome measures,Our specific interest was pacifier use related to: ,breast-feeding; ,sudden infant death syndrome; ,infection; ,dental malocclusion. Studies that examined pacifier use related to procedural pain relief were excluded. Studies that examined the relationship between pacifier use and gastro-oesophageal reflux were also excluded as this information has been recently presented as a systematic review. Search strategy, The review comprised published and unpublished research literature. The search was restricted to reports published in English, Spanish and German. The time period covered research published from January 1960 to October 2003. A protocol developed by New Zealand Health Technology Assessment was used to guide the search process. The search comprised bibliographic databases, citation searching, other evidence-based and guidelines sites, government documents, books and reports, professional websites, national associations, hand search, contacting national/international experts and general internet searching. Assessment of quality, All studies identified during the database search were assessed for relevance to the review based on the information provided in the title, abstract and descriptor/MeSH terms, and a full report was retrieved for all studies that met the inclusion criteria. Studies identified from reference list searches were assessed for relevance based on the study title. Keywords included: dummy, dummies, pacifier(s), soother(s), comforter(s), non-nutritive sucking, infant, child, infant care. Initially, studies were reviewed for inclusion by pairs of principal investigators. Authorship of articles was not concealed from the reviewers. Next, the methodological quality of included articles was assessed independently by groups of three or more principal investigators and clinicians using a checklist. All 20 studies that were accepted met minimum set criteria, but few passed without some methodological concern. Data extraction, To meet the requirements of the Joanna Briggs Institute, reasons for acceptance and non-acceptance at each phase were clearly documented. An assessment protocol and report form was developed for each of the three phases of review. The first form was created to record investigators' evaluations of studies included in the initial review. Those studies that failed to meet strict inclusion criteria were excluded at this point. A second form was designed to facilitate an in-depth critique of epidemiological study methodology. The checklist was pilot tested and adjustments were made before reviewers were trained in its use. When reviewers could not agree on an assessment, it was passed to additional reviewers and discussed until a consensus was reached. At this stage, studies other than cohort, case,control and randomised controlled trials were excluded. Issues of clarification were also addressed at this point. The final phase was that of integration. This phase, undertaken by the principal investigators, was assisted by the production of data extraction tables. Through a process of trial and error, a framework was formulated that adequately summarised the key elements of the studies. This information was tabulated under the following headings: authors/setting, design, exposure/outcome, confounders controlled, analysis and main findings. Results, With regard to the breast-feeding outcome, 10 studies met the inclusion criteria, comprising two randomised controlled trials and eight cohort studies. The research was conducted between 1995 and 2003 in a wide variety of settings involving research participants from diverse socioeconomic and cultural backgrounds. Information regarding exposure and outcome status, and potential confounding factors was obtained from: antenatal and postnatal records; interviews before discharge from obstetric/midwifery care; post-discharge interviews; and post-discharge postal and telephone surveys. Both the level of contact and the frequency of contact with the informant, the child's mother, differed widely. Pacifier use was defined and measured inconsistently, possibly because few studies were initiated expressly to investigate its relationship with breast-feeding. Completeness of follow-up was addressed, but missing data were not uniformly identified and explained. When comparisons were made between participants and non-participants there was some evidence of differential loss and a bias towards families in higher socioeconomic groups. Multivariate analysis was undertaken in the majority of studies, with some including a large number of sociodemographic, obstetric and infant covariates and others including just maternal age and education. As might be expected given the inconsistency of definition and measurement, the relationship between pacifier use and breast-feeding was expressed in many different ways and a meta-analysis was not appropriate. In summary, only one study did not report a negative association between pacifier use and breast-feeding duration or exclusivity. Results indicate an increase in risk for a reduced overall duration of breast-feeding from 20% to almost threefold. The data suggest that very infrequent use may not have any overall negative impact on breast-feeding outcomes. Six sudden infant death syndrome case,control studies met the criteria for inclusion. The research was conducted with information gathered between 1984 and 1999 in Norway, UK, New Zealand, the Netherlands and USA. Exposure information was obtained from a variety of sources including: hospital and antenatal records, death scene investigation, and interview and questionnaire. Information for cases was sought within 2 days after death, within 2,4 weeks after death and in one study between 3 and 11 years after death. Information for controls was sought from as early as 4 days of a nominated sudden infant death syndrome case, to between 1 and 7 weeks from the case date, and again in one study some 3,11 years later. In the majority of the studies case ascertainment was determined by post-mortem. Pacifier use was again defined and measured somewhat inconsistently. All studies controlled for confounding factors by matching and/or using multivariate analysis. Generally, antenatal and postnatal factors, as well as infant care practices, and maternal, family and socioeconomic issues were considered. All five studies reporting multivariate results found significantly fewer sudden infant death syndrome cases used a pacifier compared with controls. That is, pacifier use was associated with a reduced incidence of sudden infant death syndrome. These results indicate that the risk of sudden infant death syndrome for infants who did not use a pacifier in the last or reference sleep was at least twice, and possibly five times, that of infants who did use a pacifier. Three studies reported a moderately sized positive association between pacifier use and a variety of infections. Conversely, one study found no positive association between pacifier use at 15 months of age and a range of infections experienced between the ages of 6 and 18 months. Given the limited number of studies available and the variability of results, no meaningful conclusions could be drawn. Five cohort studies and one case,control study focused on the relationship between pacifier use and dental malocclusion. Not one of these studies reported a measure of association, such as an estimate of relative risk. It was therefore not possible to include these studies in the final review. Implications for practice, It is intended that this review be used as the basis of a ,best practice guideline', to make health professionals aware of the research evidence concerning these health and developmental consequences of pacifier use, because parents need clear information on which they can base child care decisions. With regard to the association between pacifier use and infection and dental malocclusion it was found that, due to the paucity of epidemiological studies, no meaningful conclusion can be drawn. There is clearly a need for more epidemiological research with regard to these two outcomes. The evidence for a relationship between pacifier use and sudden infant death syndrome is consistent, while the exact mechanism of the effect is not well understood. As to breast-feeding, research evidence shows that pacifier use in infancy is associated with a shorter duration and non-exclusivity. It is plausible that pacifier use causes babies to breast-feed less, but a causal relationship has not been irrefutably proven. Because breast-feeding confers an important advantage on all children and the incidence of sudden infant death syndrome is very low, it is recommended that health professionals generally advise parents against pacifier use, while taking into account individual circumstances. [source] Effectiveness of primary conservative management for infants with obstetric brachial plexus palsyINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 2 2005Andrea Bialocerkowski PhD MAppSc(Phty) GradDipPublicHealth Executive summary Background, Obstetric brachial plexus palsy, a complication of childbirth, occurs in 1,3 per 1000 live births internationally. Traction and/or compression of the brachial plexus is thought to be the primary mechanism of injury and this may occur in utero, during the descent through the birth canal or during delivery. This results in a spectrum of injuries that vary in severity, extent of damage and functional use of the affected upper limb. Most infants receive treatment, such as conservative management (physiotherapy, occupational therapy) or surgery; however, there is controversy regarding the most appropriate form of management. To date, no synthesised evidence is available regarding the effectiveness of primary conservative management for obstetric brachial plexus palsy. Objectives, The objective of this review was to systematically assess the literature and present the best available evidence that investigated the effectiveness of primary conservative management for infants with obstetric brachial plexus palsy. Search strategy, A systematic literature search was performed using 14 databases: TRIP, MEDLINE, CINAHL, AMED, Web of Science, Proquest 5000, Evidence Based Medicine Reviews, Expanded Academic ASAP, Meditext, Science Direct, Physiotherapy Evidence Database, Proquest Digital Dissertations, Open Archives Initiative Search Engine, Australian Digital Thesis Program. Those studies that were reported in English and published over the last decade (July 1992 to June 2003) were included in this review. Selection criteria, Quantitative studies that investigated the effectiveness of primary conservative management for infants with obstetric brachial plexus palsy were eligible for inclusion in this review. This excluded studies that solely investigated the effect of primary surgery for these infants, management of secondary deformities and the investigation of the effects of pharmacological agents, such as botulinum toxin. Data collection and analysis, Two independent reviewers assessed the eligibility of each study for inclusion into the review, the study design used and its methodological quality. Where any disagreement occurred, consensus was reached by discussion. Studies were assessed for clinical homogeneity by considering populations, interventions and outcomes. Where heterogeneity was present, synthesis was undertaken in a narrative format. Results, Eight studies were included in the review. Most were ranked low on the Hierarchy of Evidence (no randomised controlled trials were found), and had only fair methodological quality. Conservative management was variable and could consist of active or passive exercise, splints or traction. All studies lacked a clear description of what constituted conservative management, which would not allow the treatment to be replicated in the clinical setting. A variety of outcome instruments were used, none of which had evidence of validity, reliability or sensitivity to detect change. Furthermore, less severely affected infants were selected to receive conservative management. Therefore, it is difficult to draw conclusions regarding the effectiveness of conservative management for infants with obstetric brachial plexus palsy. Conclusions, There is scant, inconclusive evidence regarding the effectiveness of primary conservative intervention for infants with obstetric brachial plexus palsy. Further research should be directed to develop outcome instruments with sound psychometric properties for infants with obstetric brachial plexus palsy and their families. These outcome instruments should then be used in well-designed comparative studies. [source] Effectiveness of nurse-led cardiac clinics in adult patients with a diagnosis of coronary heart diseaseINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 1 2005Tamara Page RN BN HyperbaricNursCert GradDipNSc(HighDep) MNSc Executive summary Background, Coronary heart disease is the major cause of illness and death in Western countries and this is likely to increase as the average age of the population rises. Consumers with established coronary heart disease are at the highest risk of experiencing further coronary events. Lifestyle measures can contribute significantly to a reduction in cardiovascular mortality in established coronary heart disease. Improved management of cardiac risk factors by providing education and referrals as required has been suggested as one way of maintaining quality care in patients with established coronary heart disease. There is a need to ascertain whether or not nurse-led clinics would be an effective adjunct for patients with coronary heart disease to supplement general practitioner advice and care. Objectives, The objective of this review was to present the best available evidence related to nurse-led cardiac clinics. Inclusion criteria, This review considered any randomised controlled trials that evaluated cardiac nurse-led clinics. In the absence of randomised controlled trials, other research designs such as non-randomised controlled trials and before and after studies were considered for inclusion. Participants were adults (18 years and older) with new or existing coronary heart disease. The interventions of interest to the review included education, assessment, consultation, referral and administrative structures. Outcomes measured included adverse event rates, readmissions, admissions, clinical and cost effectiveness, consumer satisfaction and compliance with therapy. Results, Based on the search terms used, 80 papers were initially identified and reviewed for inclusion; full reports of 24 of these papers were retrieved. There were no papers included that addressed cost effectiveness or adverse events; and none addressed the outcome of referrals. A critical appraisal of the 24 remaining papers identified a total of six randomised controlled trials that met the inclusion criteria. Two studies addressed nurse-led clinics for patients diagnosed with angina, one looked at medication administration and the other looked at educational plans. A further four studies compared secondary preventative care with a nurse-led clinic and general practitioner clinic. One specifically compared usual care versus shared care introduced by nurses for patients awaiting coronary artery bypass grafting. Of the remaining three studies, two have been combined in the results section, as they are an interim report and a final report of the same study. Because of inconsistencies in reporting styles and outcome measurements, meta-analysis could not be performed on all outcomes. However, a narrative summary of each study and comparisons of specific outcomes assessed from within each study has been developed. Although not all outcomes obtained statistical significance, nurse-led clinics were at least as effective as general practitioner clinics for most outcomes. Recommendations, The following recommendations are made: ,The use of nurse-led clinics is recommended for patients with coronary heart disease (Level II). ,Utilise nurse-led clinics to increase clinic attendance and follow-up rates (Level II). ,Nurse-led clinics are recommended for patients who require lifestyle changes to decrease their risk of adverse outcomes associated with coronary heart disease (Level II). [source] A systematic review of intervention studies about anxiety in caregivers of people with dementiaINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 3 2007Claudia Cooper Abstract Background There is considerable literature on managing depression, burden and psychological morbidity in caregivers of people with dementia (CG). Anxiety has been a relatively neglected outcome measure but may require specific interventions. Objective To synthesise evidence regarding interventions that reduce anxiety in CGs. Methods Twenty-four studies met our inclusion criteria. We rated the methodology of studies, and awarded grades of recommendation (GR) for each type of intervention according to Centre for Evidence Based Medicine guidelines, from A (highest level of evidence) to D. Results Anxiety level was the primary outcome measure in only one study and no studies were predicated on a power calculation for anxiety level. There was little evidence of efficacy for any intervention. The only RCT to report significantly reduced anxiety involved a CBT and relaxation-based intervention specifically devised to treat anxiety, and there was preliminary evidence (no randomised controlled trials) that caregiver groups involving yoga and relaxation without CBT were effective. There was grade B evidence that behavioural management, exercise therapies and respite were ineffective. Limitations Many interventions were heterogeneous, so there is some overlap between groups. Lack of evidence of efficacy is not evidence of lack of efficacy. Conclusions CBT and other therapies developed primarily to target depression did not effectively treat anxiety. Good RCTs are needed to specifically target anxiety which might include relaxation techniques. Some of the interventions focussed on reducing contact with the care recipients but caregivers may want to cope with caring and preliminary evidence suggests strategies to help CGs manage caring demands may be more effective. Copyright © 2006 John Wiley & Sons, Ltd. [source] Effectiveness and acceptability of non-pharmacological interventions to reduce wandering in dementia: a systematic reviewINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 1 2007L. Robinson Abstract Background Wandering occurs in 15,60% of people with dementia. Psychosocial interventions rather than pharmacological methods are recommended, but evidence for their effectiveness is limited and there are ethical concerns associated with some non-pharmacological approaches, such as electronic tracking devices. Objective To determine the clinical and cost effectiveness and acceptability of non-pharmacological interventions to reduce wandering in dementia. Design A systematic review to evaluate effectiveness of the interventions and to assess acceptability and ethical issues associated with their use. The search and review strategy, data extraction and analysis followed recommended guidance. Papers of relevance to effectiveness, acceptability and ethical issues were sought. Results (i) Clinical effectiveness. Eleven studies, including eight randomised controlled trials, of a variety of interventions, met the inclusion criteria. There was no robust evidence to recommend any intervention, although there was some weak evidence for exercise. No relevant studies to determine cost effectiveness met the inclusion criteria. (ii) Acceptability/ethical issues. None of the acceptability papers reported directly the views of people with dementia. Exercise and music therapy were the most acceptable interventions and raised no ethical concerns. Tracking and tagging devices were acceptable to carers but generated considerable ethical debate. Physical restraints were considered unacceptable. Conclusions In order to reduce unsafe wandering high quality research is needed to determine the effectiveness of non-pharmacological interventions that are practically and ethically acceptable to users. It is important to establish the views of people with dementia on the acceptability of such interventions prior to evaluating their effectiveness through complex randomised controlled trials. Copyright © 2006 John Wiley & Sons, Ltd. [source] A systematic review of the use of simulated patients and pharmacy practice researchINTERNATIONAL JOURNAL OF PHARMACY PRACTICE, Issue 2 2006Dr. MC Watson MRC fellow Objective The use of simulated patients to assess current practice, or to derive outcome measures for pharmacy practice research, has received much attention in recent years. A simulated patient is an individual who is trained to visit a pharmacy to enact a scenario testing specific behaviour of the pharmacist or pharmacy staff. The aim of this study was to provide a definitive review of the use of simulated patients as a methodological tool for pharmacy practice research. Method A systematic review was undertaken to identify all pharmacy practice studies that had used simulated patient methodology. The electronic databases searched to identify relevant studies were MEDLINE, EMBASE and CINAHL. Articles fulfilling all the following criteria were considered for inclusion in the review: primary reports of trials conducted in community pharmacy and drug store settings which used simulated patients to derive outcome measures. The review was not restricted by language or by country. The review was restricted to publications from 1976 to May 2005. Key findings In total, 56 full publications were retrieved for further examination, of which 46 studies were included in the review, including: nine randomised controlled trials, three controlled trials, 30 cross-sectional, two time-series and two ,other' studies. Ten publications were excluded: seven reviews, one laboratory-based study, one telephone survey and one study presented only as an abstract. Conclusions There has been steady growth in the use of simulated patient methodology over the past 30 years. Although simulated patients have received negative attention in the pharmaceutical media, they can be a rigorous and robust method of measuring practice if used appropriately. This review demonstrates the range of activities for which this method can be used, including the assessment of counselling and advice provision, the treatment of minor and major illness, and the assessment of the public health activities of pharmacy and drug store staff. Simulated patient methodology has been used in developing countries to a similar, if not greater extent, than the developed world, demonstrating its versatility and applicability to pharmacy practice research globally. [source] Repeat dispensing of prescriptions in community pharmacies: a systematic review of the UK literatureINTERNATIONAL JOURNAL OF PHARMACY PRACTICE, Issue 1 2006Charles W. Morecroft Research associate Objective To identify, review and evaluate the published literature that focused on the impact of repeat dispensing in community pharmacies in the United Kingdom. Method Electronic databases (e.g. Medline, Embase and CINAHL) were searched from 1992 to May 2005. This was supplemented by searching PJ-online, IJPP online conference abstracts and the bibliographies of retrieved articles. Analysis of the findings explored the quality of the assessed papers, stakeholders' perceptions of repeat dispensing, the impact on professional relationships and workload, quality of care and prescription cost savings. Key findings Four randomised controlled trials (RCTs) and one before-and-after study were identified; most studies also incorporated a qualitative component. The findings indicated that patients' satisfaction with repeat dispensing was high, mainly as the service was seen as more convenient and time saving. While pharmacists considered that their relationship with patients had improved, one study found that patients did not necessarily agree and considered that pharmacists still remained in their dispensaries. Quality of care was considered in two RCTs, which indicated that more adverse reactions and compliance issues were identified in the intervention group. However, no direct comparisons were reported in differences in rates between intervention and control groups. Likewise, it was not possible to determine if any of the reported cost savings were solely attributable to repeat dispensing, as direct comparisons between groups were not reported. Conclusions Definitive conclusions about the effectiveness and impact of repeat dispensing are difficult to draw given a lack of transparency and systematicity when reporting these studies. Nevertheless, the findings suggest that there are high levels of patient satisfaction with the service. Likewise, it was not possible to draw conclusions about the possible savings on the NHS drug budget. Important policy decisions are being made about the implementation of repeat dispensing; however they are currently been made in a vacuum of adequate information. [source] Venous leg ulcers: patient concordance with compression therapy and its impact on healing and prevention of recurrenceINTERNATIONAL WOUND JOURNAL, Issue 5 2009Christine Moffatt ABSTRACT This study aimed to review available data on the reasons attributed to patient non concordance with compression therapy for the treatment of venous leg ulcers (VLUs), the frequency of non concordance and its effects on clinical outcomes. The biomedical literature was searched for publications on VLUs, compression therapy and concordance over the past 20 years. Physical, aesthetic and cosmetic factors, patient lack of education about VLUs, cost of therapy and issues with treatment by clinicians were all reported to influence concordance with compression therapy. The search identified 10 studies reporting patient concordance with compression stockings or bandages; while non concordance ranged from 2% to 42% of patients in three randomised controlled trials, it was generally higher in real-world studies, ranging from 9.7% to 80%. Another set of six studies indicated that the healing rate was half and the median time to complete healing was twice as long when patients were not concordant. Further, recurrence rates were 2,20 times greater when patients did not comply with the use of stockings following VLU healing. In conclusion, published biomedical literature has documented that non concordance with compression therapy negatively impacts the outcome of VLUs, highlighting the need to improve patient concordance to maximise therapeutic benefits. [source] Therapist effects in randomised controlled trials: what to do about themJOURNAL OF CLINICAL NURSING, Issue 7-8 2010Stephen J Walters Aims and objectives., The aim of this study is to describe and compare three statistical methods to allow for therapist effects in individually randomised controlled trials. Background., In an individually randomised controlled trial where the intervention is delivered by a health professional it seems likely that the effectiveness of the intervention, independent of any treatment effect, could depend on the skill of the health professional delivering it. This leads to a potential clustering of the outcomes for the patients being treated by the same health professional. Design., Retrospective statistical analysis of outcomes from four example randomised controlled trial datasets with potential clustering by health professional. Methods., Three methods to allow for clustering are described: cluster level analysis; random effects models and marginal models. These models were fitted to continuous outcome data from four example randomised controlled trial datasets with potential clustering by health professional. Results., The cluster level models produced the widest confidence intervals. Little difference was found between the estimates of the regression coefficients for the treatment effect and confidence intervals between the individual patient level models for the datasets. The conclusions reached for each dataset match those published in the original papers. The intracluster correlation coefficient ranged from <0·001,0·04 for the outcomes, which shows only minor levels of clustering within the datasets. Conclusions., The models, which use individual level data are to be preferred. Treatment coefficients from these models have different interpretations. The choice of model should depend on the scientific question being asked. Relevance to clinical practice., We recommend that researchers should be aware of any potential clustering, by health professional, in their randomised controlled trial and use appropriate methods to account for this clustering in the statistical analysis of the data. [source] Acute treatment of paediatric migraine: A meta-analysis of efficacyJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 1-2 2008Shawna Silver Aim: To undertake a meta-analysis of all randomised controlled trials (RCTs) on the acute pharmacologic treatment of children and adolescents with migraine headache. Methods: In total, 139 abstracts of clinical trials specific to the acute treatment of paediatric migraine were appraised. Inclusion criteria required clinical trials to be randomised, blinded, placebo-controlled studies with comparable endpoints. Non- English language publications were excluded. 11 clinical trials qualified for inclusion in the final meta-analysis. Two endpoints were analysed: the proportion of patients with (1) headache relief, and (2) complete pain relief, 2 h post-treatment. Results: The following medications were included in the analysis: acetaminophen (n = 1), ibuprofen (n = 2), sumatriptan (n = 5), zolmitriptan (n = 1), rizatriptan (n = 2) and dihydroergotamine (n = 1). Results are expressed as a relative benefit (RB) conferred over placebo and the number needed to treat (NNT). Only ibuprofen and sumatriptan provided a statistically significant relative efficacy in comparison with placebo. Two hours post-treatment, ibuprofen was associated with an RB 1.50 (95% CI 1.15,1.95) in the generation of headache relief (NNT 2.4) and RB 1.92 (95% CI 1.28,2.86) in the production of complete pain relief (NNT 4.9). Sumatriptan rendered an RB 1.26 (95% CI 1.13,1.41) in headache relief (NNT 7.4) and an RB 1.56 (95% CI 1.26,1.93) in the production of complete pain relief (NNT 6.9). Conclusion: Despite the pharmacological options for the management of acute migraine, few RCTs in the paediatric population exist. Composite data demonstrate that only ibuprofen and sumatriptan are significantly more effective than placebo in the generation of headache relief in children and adolescents. [source] A systematic review and meta-analysis of randomised controlled trials evaluating interventions in adult literacy and numeracyJOURNAL OF RESEARCH IN READING, Issue 3 2003Carole J. Torgerson This paper reports a systematic review of the trial literature in the field of adult literacy and numeracy. The review was undertaken to investigate the effectiveness of teaching strategies and pedagogies designed to increase adult literacy and numeracy. The objectives were to search for and locate, synthesise and quality appraise all the randomised controlled trials aiming to evaluate interventions in adult literacy and/or numeracy, published between 1980 and 2002. Fifty-nine papers were included in the descriptive map. Twelve papers were included that contained nine randomised controlled trials. All of the trials included in the review were of high quality in the sense that they had adopted an appropriate study design for assessing effectiveness. However, within that study design many of the studies had methodological problems, for example: small sample size and lack of justification of sample size calculation; unclear method of random allocation; high attrition rate and lack of ,intention to teach' analysis. There was evidence of publication bias. Pooling three studies that compared teaching against no teaching showed a strong, positive and statistically significant effect on outcome. Two other studies examined the use of computer-assisted instruction (CAI) on literacy among imprisoned adults. Pooling these two studies showed a modest but not statistically significant benefit. There is a dearth of rigorous RCTs in the field of adult literacy and numeracy. The evidence is suggestive of a benefit of adult literacy and numeracy interventions; however, because of the heterogeneity of studies, the precise role of any intervention is uncertain and this finding may be undermined by the presence of substantial publication bias. We recommend that a series of large, well-designed and well-conducted randomised trials should be undertaken in the field of adult literacy and numeracy. [source] Interventions for treating the posterior interosseus nerve syndrome: a systematic review of observational studiesJOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 2 2006Bionka M. A. Huisstede Abstract For the posterior interosseus nerve syndrome (PINS), no randomised controlled trials or controlled clinical trials about the effectiveness of interventions are available; only case series can be found. Although the validity of case series is inferior to controlled trials, they may provide valuable data about the efficacy of treatment options. Therefore, we systematically reviewed all available observational studies on treatment of PINS. A literature search and additional reference checking was done. On the basis of previous checklists, we constructed a quality assessment and rating system to analyse the included case series. Studies with less than 50% of the maximum points on the methodological quality assessment were excluded from the analysis. The results are summarised according to a rating system for the strength of the scientific evidence. Six eligible case series for this review were found. After the data extraction and methodological quality assessment, two higher quality studies that evaluated the effectiveness of surgical decompression of the PIN were included in the final analysis. There is a tendency for the effectiveness of surgical decompression of the PIN in patients with PINS. The effectiveness of a conservative treatment for PINS is unknown because no higher quality studies are available. Additional high-quality controlled studies are needed to assess the level of ,conclusive evidence' for surgical treatment. There is also a need for high-quality controlled trials into the effectiveness of conservative treatments for PINS. [source] Use of remifentanil as a sedative agent in critically ill adult patients: a meta-analysisANAESTHESIA, Issue 12 2009J. A. Tan Summary This meta-analysis examined the benefits of using remifentanil as a sedative agent in critically ill patients. A total of 11 randomised controlled trials, comparing remifentanil with another opioid or hypnotic agent in 1067 critically ill adult patients, were identified from the Cochrane controlled trials register and EMBASE and MEDLINE databases, and subjected to meta-analysis. Remifentanil was associated with a reduction in the time to tracheal extubation after cessation of sedation (weighted-mean-difference ,2.04 h (95% CI ,0.39 to ,3.69 h); p = 0.02). Remifentanil was, however, not associated with a significant reduction in mortality (relative risk 1.01 (95% CI 0.67,1.52); p = 0.96), duration of mechanical ventilation, length of intensive care unit stay, and risk of agitation (relative risk 1.08 (95% CI 0.64,1.82); p = 0.77) when compared to an alternative sedative or analgesic agent. The current evidence does not support the routine use of remifentanil as a sedative agent in critically ill adult patients. [source] A meta-analysis of the prospective randomised trials of coronary revascularisation before noncardiac vascular surgery with attention to the type of coronary revascularisation performedANAESTHESIA, Issue 10 2009B. M. Biccard Summary Prospective randomised trials of coronary revascularisation prior to noncardiac surgery have shown no survival benefit following noncardiac surgery. However, these studies have not differentiated the outcomes associated with coronary artery bypass grafting (CABG) and percutaneous coronary interventions. We performed a meta-analysis of the randomised controlled trials of pre-operative coronary revascularisation for noncardiac surgery, extracting data for 30 day and long term all-cause mortality and myocardial infarction (MI) following revascularisation, according to the type of revascularisation performed. Pre-operative percutaneous coronary intervention was associated with significantly increased 30 day MI and composite death and MI. Pre-operative CABG was associated with a significantly improved long term composite outcome of death and MI compared to percutaneous coronary interventions. The adverse effect of percutaneous coronary interventions on both short and long term outcomes in vascular surgical patients should be taken into consideration when interpreting these trials. CABG may improve long term outcomes in vascular surgical patients. The indications for and timing of CABG in vascular surgical patients needs further research. [source] Using botulinum toxin for pelvic indications in womenAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 4 2009Archana RAO Background: Botulinum toxin (BoNT) is a potent neurotoxin. Its ability to cause muscle paralysis is increasingly being utilised for the management of a number of conditions of interest to the gynaecologist. Aims: This review aims to give the reader an overview of the use of BoNT for conditions presenting a management challenge for the gynaecologist, such as chronic pelvic pain and idiopathic detrusor overactivity. Methods: The literature was reviewed regarding the use, side-effects and complications of BoNT in the pelvis, focussing on chronic pelvic pain, provoked vestibulodynia, conditions involving the lower gastrointestinal tract and detrusor overactivity. Results: In terms of pain caused by pelvic floor spasm, daily pelvic pain and dyspareunia are the symptoms most likely to be improved by BoNT. Limited data regarding use for provoked vestibulodynia indicate an improvement in pain scores. In the lower gastrointestinal tract, injection into puborectalis has been showed to objectively improve intravaginal pressures, though there are no randomised controlled trials (class I studies) validating its use in this setting. Class I studies demonstrate a role for BoNT in the management of idiopathic detrusor overactivity, though long-term follow-up data are lacking. Potential problems with BoNT injection include toxin reactions, urinary and faecal incontinence, urinary retention and secondary treatment failure due to antibody production. Conclusions: A single class I study supports the use of BoNT for refractory pelvic floor spasm; however, further adequately powered class I studies for this indication and for provoked vestibulodynia are warranted. [source] Levonorgestrel-releasing (20 ,g/day) intrauterine systems (Mirena) compared with other methods of reversible contraceptivesBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 10 2000R. S. French Research Fellow Objective To assess the relative contraceptive effectiveness, tolerability and acceptability of the levonorgestrel-releasing (20 ,g per day) intrauterine system (LNG-20) compared with reversible contraceptive methods in women of reproductive age. Design A systematic review and meta-analysis of randomised controlled trials. Identification Studies were identified through seven databases, and by contacting investigators and organisations working in the contraceptive field. Main outcome measures Unplanned pregnancy and continuation of contraceptive method. Results Five of the seven randomised controlled trials which met the inclusion criteria were included in the meta-analyses; four were comparisons of the LNG-20 intrauterine system with nonhormonal intrauterine devices. LNG-20 intrauterine systems were compared with intrauterine devices divided into two categories, those > 250 mm3 (Copper T 380 Ag and Copper T 380 A intrauterine devices) and those , 250 mm3 (Nova-T, Copper T 220C and Copper 200 intrauterine devices). Pregnancy rates for the LNG-20 intrauterine system users were significantly less likely to become pregnant compared with users of intrauterine devices , 250 mm3, and significantly less likely to have an ectopic pregnancy. LNG-20 intrauterine system users were more likely to experience amenorrhoea and device expulsion than women using intrauterine devices > 250 mm3. LNG-20 intrauterine system users were significantly more likely than all the intrauterine device users to discontinue because of hormonal side effects and amenorrhoea. When the LNG-20 intrauterine system was compared with Norplant-2, the LNG-20 users were significantly more likely to experience oligo-amenorrhoea, but significantly less likely to experience prolonged bleeding and spotting. Conclusions The effectiveness of the LNG-20 intrauterine system was similar to or better than other contraceptive methods with which it was compared. Amenorrhoea was the main reason for the discontinuation of the LNG-20 intrauterine system, usually unnecessarily, since this end-organ suppression of bleeding is benign, associated with normal oestrogen levels. Women choosing this method should be informed of potential amenorrhoea when having pre-contraceptive counselling and that absent bleeding may be viewed as a positive outcome. [source] | |||||||||||||